UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046484 |
|---|---|
| Receipt number | R000053038 |
| Scientific Title | The actual condition survey of the scalp and a home use test to verify the scalp improvement effect of shampoos |
| Date of disclosure of the study information | 2021/12/29 |
| Last modified on | 2022/02/25 15:42:41 |
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Basic information
Public title
The actual condition survey of the scalp and a home use test of shampoos
Acronym
The actual condition survey of the scalp and a home use test of shampoos
Scientific Title
The actual condition survey of the scalp and a home use test to verify the scalp improvement effect of shampoos
Scientific Title:Acronym
The actual condition survey of the scalp and a home use test of shampoos
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate scalp conditions and evaluate the scalp improvement effect of shampoos
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scalp physicality, surface ingredients
After use of placebo shampoo for 4 weeks, evaluate the dandruff and scalp itchiness before and after use of test shampoos for 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use shampoo A on head once a day for 4 weeks each
Interventions/Control_2
Use shampoo B on head once a day for 4 weeks each
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
-Healthy females aged 20 to 49 living in Tokyo suburbs
-Subjects who wash their hair more than 6 days a week
-Subjects who can accommodate restrictions (prohibition of hair coloring, bleaching, perm) during the period of participation
-Subjects who can provide consent on a voluntary basis before this study starts
Key exclusion criteria
-Subjects with suspected skin allergy, cutaneous hypersensitivity
-Subjects with severe hay fever
-Subjects who could cause skin allergy by shampoo, hair conditioner or scalp lotion
-Subjects whose skin turns red with ethanol
-Subjects with external injury, surgical treatments on test area
-Subjects with atopic dermatitis, seborrheic dermatitis on test area
-Subjects with highly exposed to sun light
-Subjects whose hair was chemically treated within one week before the start of this study
-Subjects who have rapid hair loss or hair missing in a patchy shape
-Subjects who use pharmaceuticals, hair growth agents, tonics, moisturizers, etc. on the scalp
-Subjects who regularly take vitamins and other supplements that can exhibit anti-inflammatory and dandruff-related efficacy
-Subjects who use products containing carbon dioxide (shampoos, hair conditioners, etc.) on the scalp
-Subjects who are pregnant or willing to become pregnant or are breastfeeding during the period of participation
-Subjects who are going to the hospital or taking medication due to chronic illness
-Subjects who have had strong symptoms such as shortness of breath (difficulty breathing), strong fatigue, or high fever within the past 2 weeks
-Subjects who are considered to have had close contact with a COVID-19 patient from the public health center
-Subjects who have get a COVID-19 vaccine within the past one week.
-Subjects or her family members work for a company related to the manufacture and sale of pharmaceuticals, cosmetics, toiletry products, etc.
-Subjects who participate in other surveys or studies
-Subjects who plan to participate in other studies or surveys during the study period
-Subjects deemed inappropriate to participate in this study by the person involved in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
Kao Corporation
Division name
R&D, Hair Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9872
yoshida.hiroshi1@kao.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Ebato |
Organization
Kao Corporation
Division name
R&D, Hair Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9872
Homepage URL
ebato.atsuko@kao.com
Sponsor or person
Institute
SOUKEN
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社SOUKEN（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053038
